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VRelax: reducing impact of stress in patients with psychiatric disorders - a virtual reality pilot study

VRelax: reducing impact of stress in patients with psychiatric disorders - a virtual reality pilot study - VRelax

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43327
Enrollment
30
Registered
2016-06-28
Start date
2016-06-28
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychiatric disorders stress

Interventions

Patients will be instructed to use the VRelax tool or watch the video clips twice daily for 15 minutes, once in the morning and once in the evening. The first session will be done in the presence of

Sponsors

Universitair Centrum Psychiatrie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient in clinical department of mood/anxiety disorders or psychotic disorders - DSM-IV diagnosis of depressive disorder, anxiety disorder or psychotic disorder - Age >18

Exclusion criteria

Exclusion criteria: - DSM-IV diagnosis of substance abuse or dependence - Specific phobia dolphins or water - Benzodiazepine use > 10 mg / day diazepam equivalent - Involuntary admission (IBS or RM) - Diagnosis of epilepsy or organic brain damage - Insufficient command of Dutch language

Design outcomes

Primary

MeasureTime frame
The main goal of the study is to investigate the feasibility of the VRelax tool and to evaluate the efficacy of the tool for reducing subjective and objective stress, as preparation for a larger RCT. - Subjective stress: baseline and after last session: Perceived Stress Scale, a 10-item scale to measure the degree to which situations in the last week have been appraised as stressful. Before and after each session: ecological momentary assessment single items, assessing perceived stress, anxiety, paranoia, positive and negative affect on a 1-7 ordinal scale. - Physiological stress Heart rate (HR) and skin conductance level (SCL) are recorded on the non- dominant hand in standing position for 5 minutes at baseline before session 1 but after introduction of the VRelax tool, and for 5 minutes after the first and after the last session. Skin conductance level (SCL) is measured using a sensor with two finger electrodes on the middle and ring finger of the same hand with a sampling rate of 10 Hz. Heart rate (HR) is assessed by non-invasive pulse wave measurement using a Nexus 4 with a photo-electric plethysmograph on the index finger. - Feasibility and user-friendliness will be measured using a qualitative interview after the last session (e.g., are enough patients willing to participate?, technical problems, was the intervention pleasurable / helpful, was the frequency and duration of sessions appropriate?).

Secondary

MeasureTime frame
- Type of VR environment - two conditions will be compared: dolphin and landscape environments. - Psychopathology: baseline and after last session: Inventory of Depressive Symptomatology-Self-Rated, Beck Anxiety Inventory, Green Paranoid Thoughts Scale. - Cyber sickness - Simulator sickness questionnaire (SSQ): measures simulator sickness on symptom level. - Use of anxiolytic / sedative medication - Information on frequency and dose of medication use will be collected from the patient file. - Substance use - Self-report at baseline and before each session, units of coffee, tea, cigarettes, alcohol, cannabis, illicit drugs last 24 hours or since previous session.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)